Actively Recruiting

Age: 18Years - 120Years
All Genders
Healthy Volunteers
ID00001248

Evaluation of Multiple Sclerosis Progression Using Magnetic Resonance Imaging (MRI) to Monitor Disease Activity and Immune Measures

Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-05-13

3750

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the natural history and progression of multiple sclerosis (MS) using magnetic resonance imaging (MRI) and immunological measures. This study follows patients with definite MS or those with initial neurological symptoms consistent with MS, alongside a group of healthy volunteers for comparison. The study aims to understand disease activity by examining MRI changes, clinical features, and immunological and genetic factors, both before and after the use of approved disease-modifying therapies (DMT). Participants include untreated MS patients and those starting approved therapies. Untreated patients are studied longitudinally with various MRI techniques assessing lesion activity, brain atrophy, and axonal damage. Patients beginning therapy undergo monthly MRIs before treatment to assess disease activity and are followed during therapy to explore treatment mechanisms and response. Additionally, healthy volunteers are studied to establish normal imaging and immunological benchmarks. During the study, participants undergo clinical assessments, MRI scans, and immunological and genetic testing. Samples collected are cryopreserved for future biomarker research. The main outcome measured is the rate of change in new white matter lesions over time. Follow-up visits coincide with clinical care schedules, with optional research visits possible. The study includes long-term monitoring to better understand MS progression and therapy effects.

CONDITIONS

Official Title

Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)

Who Can Participate

Age: 18Years - 120Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with multiple sclerosis based on accepted criteria or have imaging/clinical abnormalities associated with MS
  • Healthy volunteers
  • Able to give informed consent
Not Eligible

You will not qualify if you...

  • Contraindication to MRI at the time of initial enrollment (except pregnancy)
  • Unwilling to allow coded samples to be processed offsite or used in other studies

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

J

Jenifer E Dwyer

D

Daniel S Reich, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Clinical safety of serial monthly administrations of gadopentetate dimeglumine in patients with multiple sclerosis: implications for natural history and early-phase treatment trials.

R M Tresley, L A Stone, N Fields...

https://pubmed.ncbi.nlm.nih.gov/9109864

Interferon beta results in immediate reduction of contrast-enhanced MRI lesions in multiple sclerosis patients followed by weekly MRI.

P A Calabresi, L A Stone, C N Bash...

https://pubmed.ncbi.nlm.nih.gov/9153489

Increases in soluble VCAM-1 correlate with a decrease in MRI lesions in multiple sclerosis treated with interferon beta-1b.

P A Calabresi, L R Tranquill, J M Dambrosia...

https://pubmed.ncbi.nlm.nih.gov/9153530